Improving Accuracy of Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique (SAIL)

A Novel Method of Improving Accuracy of Anatomical Landmarks for Neuraxial Blocks in Pregnancy: The Sacral Anatomical Interspace Landmark (SAIL) Technique

This study is a randomized clinical trial to evaluate the accuracy of the novel SAIL technique compared to the classic intercristal line technique in estimating the L4-L5 interspace for labor epidural or spinal anesthesia placement. The investigators hypothesize that the SAIL technique will be more accurate in successfully locating the L4-L5 interspace in pregnant women than the classic intercristal line technique.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related
• Intervention / Treatment: Other: Classic Intercristal Line Technique; Other: Novel SAIL Technique

Detailed Description

The current standard technique aiming at identifying the L4-L5 intervertebral space as a reference point before performing a neuraxial block relies on the correct clinical estimation of the intercristal line. The classic intercristal line technique uses an imaginary line that intersects the iliac crests to determine a safe puncture level to access. In pregnant women, the classic technique fails to identify the safe puncture level 40 % of the time.

The newly proposed Sacral Anatomical Interspace Landmark (SAIL) technique consists of using the sacral bone to determine a safe puncture level to access.

Lumbar ultrasound will determine the accuracy of each clinical technique in identifying the L4-L5 interspace (target).

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Ultrasound-determined gestation age greater than or equal to 37 weeks
• Expressed interest or indication for epidural anesthesia
• Patients in the first stage of labor

Exclusion Criteria:

• Patients perceived or indicating that she is unable to cooperate with positioning
• BMI greater than 45 kg/m2
• Previous spine surgery or known spinal deformities
• Impaired decision making abilities
• non-English speaking

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: All Patients; Estimates of the location of the L4-L5 intervertebral space will be done by the classic intercristal line technique and novel SAIL technique. Each technique will be performed by different randomly assigned investigators. * Both techiques will be assessed on all patients

Other: Classic Intercristal Line Technique; Researcher will use the classic technique to estimate the L4-L5 interspace. The classic technique begins by palpating both the right and left posterior iliac crests and following the imaginary line that intersects each (intercristal line) with the non-dominant hand to the spine where it is estimated to intersect the L4 spinous process or L4-L5 interspace. A marker pen will mark an "X" lateral to the estimation, opposite side from the estimation of the other technique.; Other Names: Standard of Care; Other: Novel SAIL Technique; Researcher will use the novel technique to estimate the L4-L5 interspace. The SAIL technique begins by palpating the sacrum and the researcher sliding the non-dominant hand up the dorsal surface of the sacrum to the first interspace (L5-S1) and then up one more interspace to estimate the L4-L5 interspace. A marker pen will mark an "X" lateral to the estimation, opposite side from the estimation of the other technique.; Other Names: Experimental

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy, as measured by percentage of estimations that correctly match ultrasound determined interspace	Percentage of trials for the novel and classic technique respectively that the estimation correctly matches the L4-L5 interspace as determined by lumbar paramedian ultrasound will serve as a measure of accuracy	From enrollment to the end of data collection, approximately 15 minutes

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Carlo Pancaro, MD, University of Michigan

Publications and helpful links

General Publications

• Pancaro C, Rajala B, Vahabzadeh C, Cassidy R, Klumpner TT, Kountanis JA, McCabe M, Rector D, Aman C, Sankar K, Schoenfeld R, Engoren M. Sacral anatomical interspace landmark for lumbar puncture in pregnancy: A randomized trial. Neurology. 2020 Feb 11;94(6):e626-e634. doi: 10.1212/WNL.0000000000008749. Epub 2019 Dec 12.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2018
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): October 30, 2018

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 14, 2018

Study Record Updates

• Last Update Posted (Actual): November 1, 2018
• Last Update Submitted That Met QC Criteria: October 31, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Anatomical Landmarks
• Other Study ID Numbers: HUM00109509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No